NCT05543291

Brief Summary

Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

September 11, 2022

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism

    Gut metagenome, fecal metabolome and serum metabolome were performed in this disease-severity classified CKD cohort, to identify the changes of microbial compositions and metabolism in CKD progression

    baseline

Study Arms (4)

healthy controls

Behavioral: renal function

mild CKD

Behavioral: renal function

Moderate CKD

Behavioral: renal function

ESRD

Behavioral: renal function

Interventions

renal functionBEHAVIORAL

levels of eGFR

ESRDModerate CKDhealthy controlsmild CKD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: 1. Confirmed CKD patients. 2. Age≥18 years. Exclusion criteria: 1. Age\<18 years. 2. Patients with active gastrointestinal diseases, liver cirrhosis, cancer, active infection or cardiovascular event in the past 3 months, pregnancy or received renal replacement therapy.

You may qualify if:

  • Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled

You may not qualify if:

  • Age\<18 years.
  • Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy.
  • Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrolgoy, Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (1)

  • Wang H, Xue W, Cheng J, He Y, Song Y, Hu D, Peng A, Li C, Bao H. Altered fecal microbial and metabolic profiles reveal potential mechanisms underlying anemia in patients with chronic renal failure. Microbiol Spectr. 2025 Aug 5;13(8):e0316624. doi: 10.1128/spectrum.03166-24. Epub 2025 Jun 17.

Biospecimen

Retention: SAMPLES WITH DNA

Fecal and serum samples were collected for metagenome and metabolome analysis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghai tenth People's Hospital

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 16, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations